A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

UP-CLI-2019-002

This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

2020-02-22

2022-10-12

2022-10-20

Completed

Early phase I

321

Main Inclusion Criteria: * Male and female patient aged from 18 years up to 65 years, * Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, * Patient weighing \> 50 kg, * Patient who has signed a written informed consent prior to any study-related procedures. Additional inclusion criteria after surgery (randomization): 1. Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm, 2. Third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth) Main Exclusion Criteria: * Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest, * Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception, * Patient with a history of convulsive disorders, * Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine...), * Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm, * Patient with known anaemia, * Patient with known pulmonary disease, * Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding, * Patient with known glaucoma, * Patients with a prostatic hyperplasia or urinary retention, * Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities, * Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),

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2022-11-14